TDMS Study 96020-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04
EXPERIMENT: 96020 TEST: 01 TIME: 13:34:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020
PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX
------------------------------------------------------------------------------------------------------------------------------------
31 WEEK SSAC FINAL #1
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: 041499 041599
TREATMENT GROUPS: INCLUDE 001 0 NG / 0 UG
INCLUDE 002 10 NG / 10 UG
INCLUDE 003 100 NG /100 UG
INCLUDE 005 300 NG /300 UG
INCLUDE 007 1000 NG/1000 UG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153) DATE: 03/03/04
EXPERIMENT: 96020 TEST: 01 TIME: 13:34:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96020
PATHOLOGIST: SELLS, DONALD CAS: TEFBINARYMIX
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TEF EVALUATION (BINARY MIXTURE; PCB 126
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Liver Fatty Change Diffuse
Mixed Cell Focus
Pigmentation
Toxic Hepatopathy
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Hypertrophy
Multinucleated
Lung Infiltration Cellular Histiocyte
Ovary Atrophy
Pancreas: Acinus Vacuolization Cytoplasmic
Thymus Atrophy
Thyroid Gland: Follicular Cell Hypertrophy
===============================================================
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 1/1.09 2/2.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 92.2% 96.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.041 * (e) (e) P=0.500 P=0.234 |
|POLY 3 | P=0.012 * (e) (e) P=0.161 P=0.068 |
|POLY 1.5 | P=0.014 * (e) (e) P=0.189 P=0.079 |
|POLY 6 | P=0.012 * (e) (e) P=0.159 P=0.067 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.500 P=0.237 |
|ORDER RESTRICTED | P=0.324 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 2/10 (20%) 2/10 (20%) 4/10 (40%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/3.07 2/2.08 2/2.08 4/4.06 1/1.09 |
|POLY-3 PERCENT (g) | 97.9% 96.4% 96.4% 98.6% 92.2% |
|INT SACRIFICE 1 (c)| 3/10 (30%) 2/10 (20%) 2/10 (20%) 4/10 (40%) 1/10 (10%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.296N P=0.500N P=0.500N P=0.500 P=0.293N |
|POLY 3 | P=0.211N P=0.354N P=0.354N P=0.385 P=0.153N |
|POLY 1.5 | P=0.216N P=0.367N P=0.367N P=0.395 P=0.166N |
|POLY 6 | P=0.211N P=0.353N P=0.353N P=0.385 P=0.152N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.294N P=0.500N P=0.500N P=0.500 P=0.291N |
|ORDER RESTRICTED | P=0.228N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 1/1.09 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 92.2% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.161 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.189 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.159 P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 1/10 (10%) 3/10 (30%) 6/10 (60%) 5/10 (50%) |
|POLY-3 RATE (b) | 2/2.08 1/1.09 3/3.07 6/6.04 5/5.05 |
|POLY-3 PERCENT (g) | 96.4% 92.2% 97.9% 99.4% 99.1% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 1/10 (10%) 3/10 (30%) 6/10 (60%) 5/10 (50%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.061 P=0.500N P=0.500 P=0.091 P=0.180 |
|POLY 3 | P=0.041 * P=0.301N P=0.354 P=0.038 * P=0.099 |
|POLY 1.5 | P=0.041 * P=0.319N P=0.367 P=0.041 * P=0.106 |
|POLY 6 | P=0.041 * P=0.299N P=0.353 P=0.038 * P=0.099 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.085 (e) |
|COCH-ARM / FISHERS | P=0.059 P=0.500N P=0.500 P=0.085 P=0.175 |
|ORDER RESTRICTED | P=0.025 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 3/3.07 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 97.9% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.111 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.025 * P<0.001 ** P<0.001N** |
|POLY 1.5 | P<0.001 ** (e) P=0.029 * P<0.001 ** P<0.001N** |
|POLY 6 | P<0.001 ** (e) P=0.025 * P<0.001 ** P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.105 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Liver |
| Toxic Hepatopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 0/0.09 5/5.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 99.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.022 * |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.002 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.016 * |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 1/1.09 2/2.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 92.2% 96.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.041 * (e) (e) P=0.500 P=0.234 |
|POLY 3 | P=0.012 * (e) (e) P=0.161 P=0.068 |
|POLY 1.5 | P=0.014 * (e) (e) P=0.189 P=0.079 |
|POLY 6 | P=0.012 * (e) (e) P=0.159 P=0.067 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.500 P=0.237 |
|ORDER RESTRICTED | P=0.324 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 3/10 (30%) 5/10 (50%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.09 3/3.07 5/5.05 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 97.9% 99.1% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 3/10 (30%) 5/10 (50%) 10/10 (100%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.111 P=0.022 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.029 * P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.105 P=0.016 * P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Multinucleated |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 0/0.09 9/9.01 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 99.9% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 4/10 (40%) |
|POLY-3 RATE (b) | 2/2.08 1/1.09 0/0.09 1/1.09 4/4.06 |
|POLY-3 PERCENT (g) | 96.4% 92.2% 0.0% 92.2% 98.6% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 1/10 (10%) 0/10 (0%) 1/10 (10%) 4/10 (40%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) --- 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.041 * P=0.500N P=0.234N P=0.500N P=0.317 |
|POLY 3 | P=0.019 * P=0.301N P=0.068N P=0.301N P=0.204 |
|POLY 1.5 | P=0.021 * P=0.319N P=0.079N P=0.319N P=0.214 |
|POLY 6 | P=0.019 * P=0.299N P=0.067N P=0.299N P=0.203 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.040 * P=0.500N P=0.237N P=0.500N P=0.314 |
|ORDER RESTRICTED | P=0.045 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 7/10 (70%) 9/10 (90%) 10/10 (100%) 6/10 (60%) |
|POLY-3 RATE (b) | 6/6.04 7/7.03 9/9.01 10/10.00 6/6.04 |
|POLY-3 PERCENT (g) | 99.4% 99.6% 99.9% 100.0% 99.4% |
|INT SACRIFICE 1 (c)| 6/10 (60%) 7/10 (70%) 9/10 (90%) 10/10 (100%) 6/10 (60%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.365N P=0.500 P=0.157 P=0.051 P=0.672 |
|POLY 3 | P=0.312N P=0.439 P=0.115 P=0.022 * P=0.605 |
|POLY 1.5 | P=0.316N P=0.444 P=0.118 P=0.023 * P=0.610 |
|POLY 6 | P=0.312N P=0.440 P=0.116 P=0.022 * P=0.605 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.676 |
|COCH-ARM / FISHERS | P=0.363N P=0.500 P=0.152 P=0.043 * P=0.675N |
|ORDER RESTRICTED | P=0.212 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 0/0.09 3/3.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 97.9% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) (e) P=0.111 |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.025 * |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.029 * |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.025 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** (e) (e) (e) P=0.105 |
|ORDER RESTRICTED | P=0.278 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 5/10 (50%) 6/10 (60%) 7/10 (70%) 10/10 (100%) |
|POLY-3 RATE (b) | 6/6.04 5/5.05 6/6.04 7/7.03 10/10.00 |
|POLY-3 PERCENT (g) | 99.4% 99.1% 99.4% 99.6% 100.0% |
|INT SACRIFICE 1 (c)| 6/10 (60%) 5/10 (50%) 6/10 (60%) 7/10 (70%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.012 * P=0.500N P=0.672 P=0.500 P=0.051 |
|POLY 3 | P=0.010 * P=0.424N P=0.605 P=0.439 P=0.022 * |
|POLY 1.5 | P=0.010 * P=0.430N P=0.610 P=0.444 P=0.023 * |
|POLY 6 | P=0.010 * P=0.425N P=0.605 P=0.440 P=0.022 * |
|LOGISTIC REGRESSION| (e) (e) P=0.676 (e) (e) |
|COCH-ARM / FISHERS | P=0.011 * P=0.500N P=0.675N P=0.500 P=0.043 * |
|ORDER RESTRICTED | P=0.032 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 5/10 (50%) 5/10 (50%) 7/10 (70%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/0.09 5/5.05 5/5.05 7/7.03 8/8.02 |
|POLY-3 PERCENT (g) | 0.0% 99.1% 99.1% 99.6% 99.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 5/10 (50%) 5/10 (50%) 7/10 (70%) 8/10 (80%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** P=0.022 * P=0.022 * P=0.003 ** P<0.001 ** |
|POLY 3 | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.002 ** P=0.002 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P=0.007 ** P=0.016 * P=0.016 * P=0.002 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/03/04 EXPERIMENT: 96020 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TEF EVALUATION (BINARY MIXTURE; PCB 126
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG / 10 NG / 100 NG / 300 NG / 1000 NG/ |
| | 0 UG 10 UG 100 UG 300 UG 1000 UG |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 7/10 (70%) 5/10 (50%) 9/10 (90%) 4/10 (40%) |
|POLY-3 RATE (b) | 6/6.04 7/7.03 5/5.05 9/9.01 4/4.06 |
|POLY-3 PERCENT (g) | 99.4% 99.6% 99.1% 99.9% 98.6% |
|INT SACRIFICE 1 (c)| 6/10 (60%) 7/10 (70%) 5/10 (50%) 9/10 (90%) 4/10 (40%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.194N P=0.500 P=0.500N P=0.157 P=0.331N |
|POLY 3 | P=0.144N P=0.439 P=0.424N P=0.115 P=0.254N |
|POLY 1.5 | P=0.147N P=0.444 P=0.430N P=0.118 P=0.261N |
|POLY 6 | P=0.144N P=0.440 P=0.425N P=0.116 P=0.255N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.327N |
|COCH-ARM / FISHERS | P=0.192N P=0.500 P=0.500N P=0.152 P=0.328N |
|ORDER RESTRICTED | P=0.133N (e) (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).